PMA P130022S010

Device: SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
Applicant: Nevro Corporation
PMA number: P130022
Supplement: S010
Product code: LGW
Decision date: 2016-12-28
Classification: Stimulator, Spinal-cord, Totally Implanted For Pain Relief
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Approval for a manufacturing site located at Pro-Tech, 4041 Express Street, Arlington, Texas for kitting of components in cleanrooms, final packaging including labeling and visual inspection of the final product prior to shipment for sterilization.

Current openFDA PMA Record#

Device: SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
Applicant: Nevro Corporation
PMA number: P130022
Supplement: S010
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2016-12-28
Decision code: APPR
Date received: 2016-10-20
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Pro-Tech, 4041 Express Street, Arlington, Texas for kitting of components in cleanrooms, final packaging including labeling and visual inspection of the final product prior to shipment for sterilization.